Head of Quality Assurance

Piramal Pharma Solutions is seeking a dynamic and experienced Quality Operations Manager to lead our dedicated Quality Assurance Operations team at our state-of-the-art Morpeth site. This pivotal role is responsible for ensuring the highest standards of quality and compliance in the manufacture and release of pharmaceutical products, contributing directly to our mission of delivering life-changing medicines to patients worldwide. If you're a strategic leader passionate about operational excellence, regulatory compliance, and team development, we encourage you to apply.

Key Responsibilities:

Quality Leadership and Strategy:

• Provide strategic leadership and direction for all Quality Operations functions at the Morpeth site, aligning activities with long- and short-term business objectives and regulatory requirements.

• Act as the quality and regulatory point of contact for products manufactured under the Morpeth Marketing Authorization Holder (Project Agile).

GMP Compliance and Oversight:

• Ensure compliance with EU/FDA Good Manufacturing Practice (GMP) regulations throughout the manufacturing and testing processes for medicinal products for human use. This includes Manufacturing and Importation Authorisation, Manufacture of Specials, and Manufacture and Importation of Investigational Medicinal Products.
• Maintain a thorough quality oversight of internal site operations to ensure adherence to facility, system, process, and best work principles.
• Drive continuous improvement initiatives across processes and quality standards.

Team Management and Development:

• Recruit, lead, mentor, and develop the Quality Assurance department staff.
• Manage the organizational structures, policies, procedures, and processes to ensure effective and efficient use of resources.

Process Management and Improvement:

• Oversee and drive the effective management of deviations, changes, and CAPAs related to materials, facilities, processes, or procedures, ensuring timely and appropriate escalation and resolution.
• Provide QA leadership on the efficient investigation and delivery of complaints.
• Develop, monitor, and maintain procedures to ensure the manufacture and testing of pharmaceuticals, while driving continuous improvements and efficiencies.

Documentation and Batch Release:

• Manage and, where applicable, perform documentation reviews in accordance with Standard Operating Procedures (SOPs).
• Oversee batch release duties, including the issuance of Certificates of Conformance for bulk drug product.
• Ensure timely document management and performance measurement.

Escalation and Reporting:

• Immediately escalate any material breach of quality or regulatory compliance to the Site Director and Director of Quality Morpeth.

Quality Administration:

• Manage Quality Administration activities in accordance with business needs.
• Actively contribute to delivering the Quality strategy for the delivery of business-effective, compliant systems to support operations and site processes.

Cross-Functional Collaboration:

• Support the site Qualified Person (QP) in the delivery of systems and batch documents that meet the requirements for batch release to market.

Additional Responsibilities:

• Deputise where appropriate and undertake any other reasonable duties as requested by the Director of Quality Morpeth, in accordance with company requirements.